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CLDN18.2 Targeting PET Imaging in Patients With Gastrointestinal Tumors

Primary Purpose

Gastrointestinal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
124I-18B10(10L) PET/CT
Sponsored by
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Gastrointestinal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Aged >18 years old; ECOG 0 or 1;
  • 2. Patients with Gastrointestinal tumors;
  • 3. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1);
  • 4. life expectancy >=12 weeks.

Exclusion Criteria:

  • 1. Significant hepatic or renal dysfunction;
  • 2. Is pregnant or ready to pregnant;
  • 3. Cannot keep their states for half an hour;
  • 4. Refusal to join the clinical study;
  • 5. Suffering from claustrophobia or other mental diseases;
  • 6. Any other situation that researchers think it is not suitable to participate in the experiment.

Sites / Locations

  • HUA ZHURecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imaging cohort

Arm Description

All study participants will be allocated to this arm (single-arm study). Study participants will undergo 124I-18B10(10L) PET/CT scans

Outcomes

Primary Outcome Measures

Standardized uptake value（SUV）

Secondary Outcome Measures

Full Information

First Posted
May 7, 2021
Last Updated
July 18, 2022
Sponsor
Peking University Cancer Hospital & Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04883970
Brief Title
CLDN18.2 Targeting PET Imaging in Patients With Gastrointestinal Tumors
Official Title
CLDN18.2 Targeting 124I-18B10(10L) PET Imaging in Patients With Gastrointestinal Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 13, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The objective of the study is to constrcut a noninvasive approach 124I-18B10(10L) PET/CT to detect the CLDN18.2 expression of tumor lesions in patients with gastrointestinal tumors and to identify patients benefiting from CLDN18.2 targeting treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Imaging cohort
Arm Type
Experimental
Arm Description
All study participants will be allocated to this arm (single-arm study). Study participants will undergo 124I-18B10(10L) PET/CT scans
Intervention Type
Other
Intervention Name(s)
124I-18B10(10L) PET/CT
Intervention Description
Study participants will undergo 124I-18B10(10L) PET/CT scans
Primary Outcome Measure Information:
Title
Standardized uptake value（SUV）
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Aged >18 years old; ECOG 0 or 1; 2. Patients with Gastrointestinal tumors; 3. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1); 4. life expectancy >=12 weeks. Exclusion Criteria: 1. Significant hepatic or renal dysfunction; 2. Is pregnant or ready to pregnant; 3. Cannot keep their states for half an hour; 4. Refusal to join the clinical study; 5. Suffering from claustrophobia or other mental diseases; 6. Any other situation that researchers think it is not suitable to participate in the experiment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hua Zhu
Phone
010-88196495
Email
zhuhuabch@pku.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hua Zhu
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
HUA ZHU
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hua Zhu
Phone
010-88196495

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

CLDN18.2 Targeting PET Imaging in Patients With Gastrointestinal Tumors

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